MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUE METRIX; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number	STRIP, WGN TMX 60CT 12/CASE MG/DL
Medical Device Problem Codes	High Test Results (2457); Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Test strips were returned for evaluation.Product testing was performed and no defect found on returned test strips.Meter was not returned for evaluation - customer returned incorrect meter (scrapped).Retention testing was performed using test strips from the same lot.Retention strip lot passed within specifications.Most likely underlying root cause: mlc-062: user had poor technique.Note: manufacturer contacted customer in a follow-up call on 26-feb-2026 to ensure the replacement products resolved the initial concern - able to establish contact with customer who indicated replacement products resolved initial concern.
Event or Problem Description
Consumer reported complaint for high and erratic blood glucose test results.Husband is calling on behalf of the customer.The customer called concerned with test results from results obtained of 130, 132 and 244 mg/dl.Caller stated the customer's expected am fasting blood glucose test result range is 90-110 mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call, a back to back blood test was not performed by the customer.Per caller the product is being stored outside of the large kitchen.The test strip lot manufacturer¿s expiration date is 04/30/2027 and per the customer the open vial date is 1 week.The meter memory was reviewed for previous test result history (time on the meter is incorrect, all bloods were done in the am): result 1: 130 mg/dl, date: (b)(6), time: 12:02pm fasting, result 2: 93 mg/dl , date: (b)(6), time: 12:01pm fasting, result 3: 103 mg/dl , date: (b)(6), time: 12:15pm fasting , result 4: 98 mg/dl , date: (b)(6), time: 12:15pm fasting, result 5: 93 mg/dl , date: (b)(6), time: 12:03pm fasting, result 6: 132 mg/dl , date: (b)(6), time:12:01pm fasting, result 7: 100 mg/dl , date: (b)(6), time: 12:01pm fasting, result 8: 244 mg/dl , date: (b)(6), time:11:57am fasting.

• Brand Name: TRUE METRIX
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: juliana arias ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 24594827
• Report Number: 1000113657-2026-00111
• Device Sequence Number: 10326236
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120(17)270430(10)ZD6241S
• Combination Product (Y/N): N
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: STRIP, WGN TMX 60CT 12/CASE MG/DL
• Device Lot Number: ZD6241S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2026
• Distributor Facility Aware Date: 02/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown